Cleared Traditional

K820251 - T4 DIAGNOSTIC KIT

K820251 is an FDA 510(k) clearance for T4 DIAGNOSTIC KIT, manufactured by Diagnostic Reagents, Inc.. The device is a Class 2 Chemistry device with product code CDP cleared through the Traditional 510(k) pathway after a 96-day FDA review.

K820251 · Diagnostic Reagents, Inc. · Chemistry device
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May 1982
Decision
96d
Days
Class 2
Risk

K820251 is an FDA 510(k) clearance for the T4 DIAGNOSTIC KIT. Classified as Radioimmunoassay, Total Triiodothyronine (product code CDP), Class II - Special Controls.

Submitted by Diagnostic Reagents, Inc. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 96 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1710 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Diagnostic Reagents, Inc. devices

FDA 510(k) Submission Details - K820251

510(k) Number K820251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1982
Decision Date May 05, 1982
Days to Decision 96 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 88d · This submission: 96d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDP Device Classification - Class 2, Special Controls

Product Code CDP Radioimmunoassay, Total Triiodothyronine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1710
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - CDP Radioimmunoassay, Total Triiodothyronine

All 118
Devices cleared under the same product code (CDP) and FDA review panel - the closest regulatory comparables to K820251.
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K821725 · Diagnostic Reagents, Inc. · Jun 1982
ENZYM-LINKED T3
K820763 · Icl Scientific · Apr 1982
QUANTICOAT NEONATAL 125 T4 RADIOIMMUNO
K812611 · Kallestad Laboratories, Inc. · Oct 1981
THYROXINE (T4) 125I
K812666 · Pcl-Ria, Inc. · Oct 1981